Depression, Anxiety Clinical Trial
Official title:
iWellness Study: Evaluation of a CBT Chatbot App to Promote Mental Wellness in Students
Verified date | March 2023 |
Source | Harvard University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The study aims to evaluate whether use of a mobile mental health app improves outcomes of depression and anxiety for students.
Status | Completed |
Enrollment | 289 |
Est. completion date | December 31, 2022 |
Est. primary completion date | December 31, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Participants will be required to be at 18 years or older - Own a smartphone with Wi-Fi or 3G/4G capabilities - Current student at Harvard University - A PHQ-9 score of 5 or greater (indicating mild symptoms of depression or greater), or a score of 2 or greater on PHQ item 10 (indicating that they felt disabled in their life because of their mood) or a GAD-7 score of 8 or greater (indicating mild symptoms of anxiety or greater) will be required for enrollment. Exclusion Criteria: - Those who score less than 5 on PHQ-9 or less than 8 on the GAD-7 during study screening will be excluded from the study. - Anyone who indicates thoughts of harm to themselves or others (PHQ-9 item 9 score > 0) during initial screening will be excluded from participation in the study. - Participants with a PHQ-9 Q9 suicide item score > 0 will receive an automated notification that they are not eligible to participate in the study and that they should call the Harvard Counseling and Mental Health Services 24/7 line. Study staff will also inform Chief of HUHS CAMHS to reach out to the participant. |
Country | Name | City | State |
---|---|---|---|
United States | Harvard University Health Services | Cambridge | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Harvard University |
United States,
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* Note: There are 19 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Depression - Patient Health Questionnaire - 9 (PHQ-9) | PHQ-9: A 9-question multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression.
Scoring: Scoring: 0-3 Scale for each item; 0 Not at all; 3 Nearly every day The nine item version of the PHQ-9 was designed to facilitate the recognition and diagnosis of depression in primary care patients. It can be used to monitor change in symptoms over time and provides a depression severity index score as follows: 0-4 None 5-9 Mild 10 - 14 Moderate 15 - 19 Moderately Severe 20 - 27 Severe The recommended cut-off for the PHQ-9 severity index is a score of 9. Anyone who scores 10 or above can be considered to be suffering from clinically significant symptoms of depression. |
8 weeks | |
Primary | Anxiety - Generalized Anxiety Disorder 7-item scale (GAD-7) | GAD-7: A diagnostic self-report 7-item scale for screening, diagnosis, and severity assessment of generalized anxiety disorder.
Scoring: 0-3 Scale for each item; 0 Not at all; 3 Nearly every day The index scores are as follows: 0-4 None 5-10 Mild Anxiety 11 - 15 Moderate Anxiety 15 - 21 Severe Anxiety The recommended cut off for the GAD-7 severity index is a score of 7. Anyone who scores 8 or above can be considered to be suffering from clinically significant anxiety symptoms. |
8 weeks | |
Secondary | Perceived Stress - Perceived Stress Scale (PSS) | PSS: A psychological instrument for measuring the perception of stress by asking about feelings and thoughts during the last month.
PSS scores are obtained by reversing responses (e.g., 0 = 4, 1 = 3, 2 = 2, 3 = 1 & 4 = 0) to the four positivelystated items (items 4, 5, 7, & 8) and then summing across all scale items. A short 4 item scale can be made fromquestions 2, 4, 5 and 10 of the PSS 10 item scale. |
8 weeks | |
Secondary | Loneliness - Hughes Loneliness scale | Hughes Loneliness scale: This is a scale used to assess feelings of loneliness or social isolation. The Three-Item Loneliness Scale is a questionnaire developed from the Revised UCLA Loneliness Scale.
Each question is rated on a 3-point scale: = Hardly Ever = Some of the Time = Often. Scoring: All items are summed to give a total score. Higher scores indicate greater degrees of loneliness. |
8 weeks |
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